Last reviewed 2026-06-01 · How we verify

Lapelga

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 3 active Small molecule ✓ Verified Jun 2026

Lapelga is a Small molecule drug developed by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. It is currently in Phase 3 development. Also known as: biosimilar pegfilgrastim.

Lapelga is a biosimilar of Pegfilgrastim, a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It is used to stimulate the production of white blood cells (neutrophils) in patients with conditions such as multiple myeloma, lymphoma, and febrile neutropenia.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Lapelga
Also known as	biosimilar pegfilgrastim
Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Lapelga vs Gastrofil (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Lapelga CI brief — competitive landscape report
Lapelga updates RSS · CI watch RSS
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's portfolio CI

Frequently asked questions about Lapelga

What is Lapelga?

Lapelga is a Small molecule drug developed by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.

Who makes Lapelga?

Lapelga is developed by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (see full London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's pipeline at /company/london-health-sciences-centre-research-institute-or-lawson-research-institute-of).

Is Lapelga also known as anything else?

Lapelga is also known as biosimilar pegfilgrastim.

What development phase is Lapelga in?

Lapelga is in Phase 3.

Manufacturer: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's — full pipeline
Therapeutic area: All drugs in Other
Also known as: biosimilar pegfilgrastim

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing